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临床试验/NCT01535326
NCT01535326已完成不适用

Comparing Air Insufflation, Water Immersion and Water Exchange Methods During Minimal Sedated Colonoscopy, a Randomized, Controlled Trial

Dalin Tzu Chi General Hospital2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
270
试验地点
2
主要终点
Proportion of Patients Without Pain

研究概览

简要总结

In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange).

This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.

详细描述

All procedures will be recorded and stored as digital files.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing minimally sedated colonoscopy

排除标准

  • •Obstructive lesions of the colon, inadequate bowel preparation, allergy to meperidine, massive ascites, past history of partial colectomy, or refusal to provide written informed consent.

研究组 & 干预措施

water immersion

Active Comparator

infuse water during insertion, remove water during withdrawal of colonoscopy

干预措施: water immersion (Procedure)

water exchange

Active Comparator

infuse and remove water during insertion phase of colonoscopy

干预措施: water exchange (Procedure)

air insufflation

Placebo Comparator

Use air insufflation during colonoscopy

干预措施: air insufflation (Procedure)

结局指标

主要结局

Proportion of Patients Without Pain

时间窗: up to 12 months

proportion of patients without insertion pain during colonoscopy

次要结局

  • Patient Pain Score(9 to 12 months)
  • Patient Satisfaction Score(9 to 12 months)
  • Number of Participants With at Least One Adenoma(9 to 12 months)

研究者

发起方
Dalin Tzu Chi General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-Hsi hsieh

Chief of department of gastroenterology and hepatology

Dalin Tzu Chi General Hospital

研究点 (2)

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